Shire launches rare-disease research project

LEXINGTON, Mass. — Drug maker Shire has started a research program focused on rare diseases and their effects on patients and healthcare professionals, the company said Monday.

Shire announced the launch of the Shire Rare Disease Impact Report, which includes surveys of patients, caregivers, physicians, payers and others in the United States and United Kingdom, with results expected in the first half of 2013.

According to the Global Genes Project, about 7,000 types of rare diseases affect an estimated 350 million people worldwide and are often chronic, progressive, degenerative, life-threatening and disabling.

"Despite the progress that has been made over the past few decades in the rare disease space, there is still an urgent need to better understand this community and its needs," said Nicole Boice, founder and CEO of the Global Genes I R.A.R.E. Project and a member of the project’s advisory board. "I’m thrilled to be involved in the development of this Rare Disease Impact Report, as its findings will help elevate awareness for the rare disease community and guide future research and education for affected patients and their families."

Other members of the advisory board are Priya S. Kishnani, Duke University Medical Center division chief for medical genetics; Tomas Philipson, professor of public policy studies at the University of Chicago; Alastair Kent, director of the Genetic Alliance UK; Christian Hendriksz, clinical lead for adult inherited metabolic disorders at the United Kingdom’s Salford Royal NHS Foundation Trust; and Mike Drummond, professor of health economics at the University of York.

"At Shire, patients are at the heart of everything we do, and we continually strive to provide support for those touched by rare diseases," Shire HGT president Sylvie Gregoire said. "We hope the findings from this Rare Disease Impact Report will provide the rare disease community at large with new, unique insights on how best to address the holistic needs of the rare disease community and drive important conversations and innovation."

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As Specialty Pharmacy magazine reported in its fall 2012 issue, specialty drug development is starting to play a much bigger role in drug development overall than traditional pharmaceuticals. According to the IMS Institute for Healthcare Informatics, seven of the top 20 drug therapy classes will be in specialty by 2016, including cancer, autoimmune disorders and antivirals, and specialty and bioengineered drugs remain one of the few growth centers in the drug industry in 2012. And according to Express Scripts, the market for specialty and bioengineered drugs is expected to grow from 2011’s 17.1% to 22% by 2014.

A quick look at the state of the drug industry shows where things are going as well. While many branded drug companies have shifted significant development into specialty — with Pfizer, Merck and Bristol-Myers Squibb serving as prominent examples — generic drug makers are looking to get into the action with biosimilars. In October 2012, Sandoz started a phase-3 trial of a biosimilar version of Amgen’s anemia drug Epogen (epoetin alfa) and is conducting trials of other biosimilars, while Teva won Food and Drug Administration approval for Tbo-filgrastim, a biosimilar of Amgen’s Neupogen (filgrastim), used to treat reduced white blood cell counts in patients on chemotherapy, in August 2012.

In other words, whether doing it through mergers and acquisitions, like Kroger, or through partnerships, like Hy-Vee’s deal with Amber Pharmacy, retailers that don’t take advantage of specialty pharmacy have little to gain and much to lose.

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